John Lancaster Email Address
@ljpc.com
Senior Director, Pharmaceutical Operations
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. The Company has several product candidates in development. LJPC-501 is La JollaUas proprietary formulation of angiotensin II for the potential treatment of catecholamine-resistant hypotension.
Product Development with Quality and Regulatory Emphasis • Drug Substance/API: CMO Management for Process Development, GMP Manufacturing, MIP • Drug Product: CMO Management for Formulation Development, Method Transfer, Site Transfer, GMP Manufacturing • Quality: GXP Quality Systems, Quality Audits, GMP Training Material Development, SOP Development • Biologics: Manufacturing Process, Development of QC Assays, GMP Sterile Fill Manufacturing • Project Management: Timeline Management, Contractor Management, Team Development • Regulatory Submissions (NDA, IND, IMPD, updates) Specialties: CMC Development, Supplier/CMO Management, Quality System Implementation and Management, Regulatory Strategy and Submissions, Validation and Technical Writing
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